MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSMBLY; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	0500316N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
It was reported to fresenius by a nephrologist that this patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) experienced a reported reaction (specifics not provided) to the optiflux 160nr dialyzer (date not provided).During intake, the physician was questioning why a specific patient would experience a reaction to electron beam sterilization and not to other methods of sterilization.Subsequent attempts to obtain additional information (e.G., patient demographics, treatment records, medical records) have thus far proven unsuccessful.
Event or Problem Description
It was reported to fresenius by a nephrologist that this patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) experienced a reported reaction (specifics not provided) to the optiflux 160nr dialyzer (date not provided).During intake, the physician was questioning why a specific patient would experience a reaction to electron beam sterilization and not to other methods of sterilization.Subsequent attempts to obtain additional information (e.G., patient demographics, treatment records, medical records) have thus far proven unsuccessful.
Additional Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.As no lot number was provided for this complaint, an search was performed to obtain all lot numbers with the reported catalog number delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date.Twelve lots were found to have been delivered in this time period.A production records review was performed on the reported lots.An investigation of the device history records (dhr) was conducted by the manufacturer.There was no indication of product non-acceptance or deviation in the manufacturing process related to the complaint event.This includes non-conformances, rework, labeling, process controls, and any other occurrence in production that was potentially related to the complaint.The lots met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.
Event or Problem Description
It was reported to fresenius by a nephrologist that this patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) experienced a reported reaction (specifics not provided) to the optiflux 160nr dialyzer (date not provided).During intake, the physician was questioning why a specific patient would experience a reaction to electron beam sterilization and not to other methods of sterilization.Subsequent attempts to obtain additional information (e.G., patient demographics, treatment records, medical records) have thus far proven unsuccessful.

• Brand Name: OPTIFLUX 160NRE DIALYZER FINISHED ASSMBLY
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• MDR Report Key: 11925487
• Report Number: 1713747-2021-00168
• Device Sequence Number: 804887
• Product Code: KDI
• UDI-Device Identifier: 00840861100118
• UDI-Public: 00840861100118
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K002761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0500316N
• Device Catalogue Number: 0500316E
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 07/08/2021; 08/17/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/28/2021; 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention